Overview
ImmunityBio Inc. (NASDAQ: IBRX) experienced an 8.6% increase in premarket trading on Wednesday following confirmation from the U.S. Food and Drug Administration that it has accepted a supplemental Biologics License Application (sBLA) for ANKTIVA administered in combination with Bacillus Calmette-Guérin (BCG). The filing seeks an expanded indication for treating patients who have BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) presenting with papillary disease and no carcinoma in situ (CIS).
Regulatory timeline and review focus
The FDA assigned a PDUFA target action date of January 6, 2027. In its notice, the agency said the regulatory review will concentrate on scientific evidence that describes overlapping features between papillary disease and CIS to determine whether that evidence adequately supports broadening ANKTIVA's approved indication.
Clinical evidence supporting the supplemental filing
The supplemental application is supported by results from the QUILT 3.032 Phase 2/3 trial, specifically Cohort B, which enrolled 80 patients with high-grade papillary-only NMIBC. According to data published in The Journal of Urology, the trial met its primary endpoint with a 12-month disease-free survival rate of 58.2%.
Secondary endpoints reported in the publication include progression-free survival of 94.9% at 12 months and 82.0% at 36 months. Cystectomy-free survival was listed as 92.2% at 12 months and 83.1% at 36 months. Disease-specific survival reached 96.0% at 36 months.
Existing approval and patient population
ANKTIVA in combination with BCG was approved by the FDA in April 2024 to treat adult patients with BCG-unresponsive NMIBC that includes carcinoma in situ, with or without papillary tumors. The filing now seeks to extend that indication to the subset of patients who present with papillary disease only. The source material notes that approximately 85% of the roughly 64,000 people diagnosed with NMIBC in the United States each year present with papillary disease.
Context from FDA workshop and guideline alignment
During an FDA workshop on May 18, 2026, panelists stated that CIS and papillary disease arise from the same cancer-inducing clone and observed that clinicians already treat patients with papillary disease alone using off-label FDA-approved therapies that address CIS and papillary disease. The article states this assessment was consistent with the National Comprehensive Cancer Network's March 2026 decision to designate treatment of BCG-unresponsive NMIBC papillary disease as a Category 2A guideline.
Implications
The FDA's acceptance of the sBLA initiates a formal review that will test whether the scientific overlap between papillary disease and CIS supports expanding ANKTIVA's indication. The company’s supplemental filing relies on the outcomes reported in a single Phase 2/3 cohort of 80 patients, and the PDUFA target date sets a clear regulatory timeline for a decision.